Taking people in ChinaPhase 2/3

Tests azacitidine plus venetoclax to see if it delays leukemia returning in younger adults

Tests a two-drug maintenance treatment in younger adults with leukemia in remission.

Plain-language title generated from the registry record
Registry title: AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Key facts

Where: Suzhou, ChinaSee the 2 sites
Phase: Phase 2/3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-64 with favorable-risk acute myeloid leukemia (AML) in first remission after intensive chemotherapy, who are not immediate candidates for a stem cell transplant.

Age: 18-64 years.
Sex: All sexes can join.
Disease stage: Favorable-risk AML (2017 European LeukemiaNet genetic risk), in first remission after induction and consolidation chemotherapy. ECOG performance status of 3 or lower.
Earlier treatment: Must have had remission induction therapy and 3-4 cycles of high-dose or medium-dose cytarabine-based consolidation. Not an immediate candidate for allogeneic stem cell transplant.
Biomarker or test result: Favorable-risk genetic profile according to the revised 2017 European LeukemiaNet classification. Adequate liver, kidney and heart function (for example creatinine clearance of 60 ml/min or higher, left ventricular ejection fraction of 50% or higher).

Main reasons for not taking part

Acute promyeloid leukemia
Active leukemia in the central nervous system
AML that developed from earlier myelodysplastic syndrome or myeloproliferative neoplasm
Other progressive cancers
Uncontrolled or active infection, or pregnant or breastfeeding

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 64 years old?

Source: NCT05404906, who can take part

Where in China

First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Suning Chen, PhDTaking people
The First Affiliated Hospital of Soochow University, Jiangsu Institute of HematologySuzhou, ChinaContact: Suning Chen, ProfessorTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: The First Affiliated Hospital of Soochow University
Trial code: NCT05404906
Record updated: 19 August 2022
Original description: This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.Read full original descriptionShow less
Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
Inclusion: Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratiﬁcation and are not immediate candidates for allogeneic stem cell transplant; Aged 18-64 years; Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission; ECOG performance status of < or = 3; Adequate organ function as follows:; Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN); Aspartate Transaminase and alanine transaminase < or = to 3 x ULN; Ccr（Creatinine Clearance Rate) > or ＝60 ml/min; Left ventricular ejection fraction > or ＝50% determined by ultrasound; For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling; For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment; Ability to understand and sign informed consent.
Exclusion: Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML; Patients who have participated in other trials within 30 days before signing the informed consent; Patients with other progressive malignancies; Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal); Acute promyeloid leukemia; Patients with active central nervous system (CNS) leukemia; Females who are pregnant or lactating or intending to become pregnant during the study.
ClinicalTrials.gov NCT05404906